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Clinical Trials/NCT06540794
NCT06540794CompletedNot Applicable

Evaluation of the Respiratory Effects of Driving Pressure Guided Mechanical Ventilation Using Electrical Impedance Tomography in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

Istanbul University1 site in 1 country42 target enrollmentStarted: August 6, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
The primary outcome was the comparison of dorsal ventilation (ROI 3+4) between the two groups, as assessed by EIT.

Study Overview

Brief Summary

Robot-Assisted Laparoscopic Radical Prostatectomy is a method increasingly used for prostate cancer due to fewer complications, morbidity, and mortality compared to other methods. The technique involves inflating the abdomen with carbon dioxide to provide visualization and working in a steep Trendelenburg position, which puts pressure on the lungs and can cause them to collapse. The functional residual capacity reduction caused by general anesthesia, combined with the negative effects of the position, increases the risk of significant respiratory system complications during and after surgery.

Lung protective ventilation strategies can reduce the incidence of postoperative pulmonary complications (PPC) by alleviating iatrogenic injury to previously healthy lungs. Apart from a low tidal volume (VT), applying positive end-expiratory pressure (PEEP) can minimize the risk of atelectasis and/or overdistension.

There is limited information on how to adjust optimal PEEP under increased intra-abdominal pressure during laparoscopy. A meta-analysis study on acute respiratory distress syndrome (ARDS) patients showed that high driving pressure (plateau pressure - PEEP) is the most associated value with mortality. It was shown that VT, plateau pressure, and PEEP are not related to patient outcomes or only when they affect driving pressure. Subsequent retrospective and prospective studies confirmed the importance of driving pressure in ARDS patients and surgical patients.

For patients under mechanical ventilation, applying a personalized PEEP that provides the lowest driving pressure, along with maneuvers to open closed alveoli (recruitment), reduces respiratory system complications during and after surgery. One method to visualize the effects of these maneuvers and the ideal PEEP application, which provides the lowest driving pressure for the patient, is electrical impedance tomography (EIT), a non-invasive, radiation-free bedside imaging technique.

EIT, measured with 16 electrodes placed on an elastic belt around the patient's 4th to 6th ribs, shows impedance changes in the lungs. This method successfully visualizes and evaluates dynamic changes in gas distribution within the lungs and has been validated by computed tomography scans, proving safe for use in both adults and pediatric patients. EIT divides the lungs into four layers from ventral to dorsal, showing the percentage distribution of tidal volume in these regions. Examining the relative impedance changes allows for observing gas volume distribution entering the lungs and evaluating regional lung characteristics.

Therefore, EIT can contribute to examining the PEEP value that ensures homogeneous gas distribution in the lungs and preventing ventilator-associated lung injury.

The aim of our study is to evaluate the effect of driving pressure guided mechanical ventilation on lung gas distribution during robot-assisted laparoscopic radical prostatectomy through respiratory parameters recorded by EIT during surgery and perioperative period and to compare perioperative pulmonary complications with traditional ventilation methods

Detailed Description

General anesthesia increases the risk of respiratory complications and impairs arterial oxygenation by causing atelectasis in the dorsal regions of the lungs. Postoperative pulmonary complications (PPC) represent events such as atelectasis, pulmonary edema, pneumonia, pleuritis, reintubation, and the need for oxygen support after surgery, and are associated with increased morbidity, mortality, intensive care, and hospital stay durations, as well as higher healthcare costs. The effective strategy to reduce the incidence of PPC in patients under general anesthesia is still not clear.

Robot-assisted surgeries are increasingly preferred for prostatectomy, a curative treatment for prostate cancer, due to advantages such as less blood loss, less scar tissue formation, and shorter hospital stays compared to other surgical methods. During robotic surgery, many factors such as laparoscopy, pneumoperitoneum, and extreme Trendelenburg position can negatively affect lung function. Studies have shown that high driving pressure values, resulting from the set tidal volume target and PEEP values during mechanical ventilation, increase postoperative pulmonary complications.

Developing mechanical ventilation strategies based on personalized PEEP values that provide the lowest driving pressure after recruitment maneuvers to include closed alveoli in respiration and monitoring the effects of this method on the lungs during the perioperative period using electrical impedance tomography (EIT) is a highly useful tool. EIT, a non-invasive, radiation-free bedside monitoring system that detects real-time regional ventilation changes, can be used to guide individualized protective ventilation strategies to reduce perioperative respiratory system complications. Examining ROI values measured by EIT shows the effect of ventilation strategies on the distribution of tidal volume in the lungs. ROIs calculated by selecting layers, with ROI 1 and ROI 2 reflecting the ventral parts and ROI 3 and ROI 4 reflecting the dorsal parts, can be used to demonstrate the effect of the chosen ventilation strategy on lung gas distribution through intergroup comparison.

The age, gender, height, weight, body mass index, diagnosis, ASA score, preoperative hemoglobin level, additional systemic diseases, smoking history, prostate-specific antigen level, Gleason score, and prostate volume of the patients will be recorded. All patients will be monitored with electrocardiogram (ECG), peripheral oxygen saturation (SpO2), invasive arterial pressure (systolic arterial pressure, diastolic arterial pressure, and mean arterial pressure), and electrical impedance tomography. Patients will be prospectively randomized into two groups; group assignments will be determined using a closed-envelope technique.

All patients will be preoxygenated with 80% FiO2, followed by induction of anesthesia with 2 mcg/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium. After orotracheal intubation, patients will be placed on mechanical ventilation in volume control-autoflow mode with 8 ml/kg tidal volume, 2 L/min fresh gas flow, 0.4 inspired fractional oxygen (FiO2), an inspiratory: expiratory ratio of 1:2, and a respiratory rate to achieve normocapnia (partial carbon dioxide pressure PaCO2: 35-45 mmHg). Recruitment maneuvers will be applied to all patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
— to 80 Years (Child, Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •ASA score of I-II-III according to the American Society of Anesthesiologists (ASA) physical status classification system
  • •Surgery duration is expected to be longer than 2 hours

Exclusion Criteria

  • •Patients who underwent surgery requiring mechanical ventilation for more than 1 hour within 2 weeks before the operation
  • •Patients with a body mass index over 35
  • •Patients with large bullae or pneumothorax, those currently receiving oxygen support, those with severe respiratory disease
  • •Patients with severe heart failure classified as NYHA class III-IV by the New York Heart Association (NYHA), those with a pacemaker or cardiac defibrillator implant
  • •Patients with progressive neuromuscular disease
  • •Patients who refused to participate in the study were excluded.

Arms & Interventions

Group sPEEP (standard positive end-expiratory pressure)

No Intervention

Patients in this group will receive mechanical ventilation with a PEEP value of 5 cmH2O, following the recruitment maneuver.

Group kPEEP (personalized positive end-expiratory pressure)

Experimental

A decremental PEEP titration strategy will be chosen after recruitment to determine the PEEP value that provides the lowest driving pressure. The personalized PEEP value (kPEEP) that provides the lowest driving pressure will be measured and maintained throughout the mechanical ventilation period. To find this value, the PEEP level will first be set at 15 cmH2O and maintained for 12 breathing cycles, after which the driving pressure will be recorded. Subsequently, the PEEP level will be decreased by 1 cmH2O and maintained for 12 breathing cycles, with the driving pressure recorded at each level. This strategy will continue until the PEEP level reaches 5 cmH2O. During these measurements, the tidal volume will be set at 8 ml/kg, the respiratory rate at 12 breaths/min, and the inspiratory: expiratory ratio at 1:2. The PEEP value that provides the lowest driving pressure will be recorded as kPEEP and maintained during pneumoperitoneum.

Intervention: PEEP TITRATION (Other)

Outcomes

Primary Outcomes

The primary outcome was the comparison of dorsal ventilation (ROI 3+4) between the two groups, as assessed by EIT.

Time Frame: peroperative

The ROI values measured by electrical impedance tomography for all patients were recorded before intubation, immediately after intubation, at the 15th, 60th, and 120th minutes of pneumoperitoneum and Trendelenburg position, before extubation in the supine position, and 5 minutes after extubation.

Secondary Outcomes

  • GI index(iImmediately after intubation, pre-extubation (supine) and 5 minutes post-extubation.)
  • Oxygenation (PaO₂/FiO₂ Ratio)(Intraoperative and immediate postoperative period, up to 5 hours: baseline (pre-induction), immediately after intubation (before pneumoperitoneum), 15, 60 and 120 minutes after pneumoperitoneum and Trendelenburg positioning, immediately before extubation)
  • Airway Pressures (Ppeak, Pplat, PEEP, ΔP)(Intraoperative period, up to 5 hours: immediately after intubation (before pneumoperitoneum); 15, 60, 75, 90 and 120 minutes after pneumoperitoneum and Trendelenburg positioning; and immediately before extubation.)
  • Heart Rate(Baseline (pre-induction) through 48 hours postoperatively: immediately after intubation; 15, 60, 75, 90 and 120 minutes after pneumoperitoneum and Trendelenburg positioning; immediately before extubation; 5 minutes after extubation; and 1, 24 and 48 hour)
  • Incidence of Postoperative Pulmonary Complications (PPCs)(Assessed by blinded investigators at 1 hour, 24 hours, and 48 hours post-operation.)
  • Dynamic Compliance(Intraoperative period, up to 5 hours: immediately after intubation (before pneumoperitoneum); 15, 60, 75, 90 and 120 minutes after pneumoperitoneum and Trendelenburg positioning; and immediately before extubation.)
  • Mean Arterial Pressure (MAP)(Baseline (pre-induction) through 48 hours postoperatively: immediately after intubation; 15, 60, 75, 90 and 120 minutes after pneumoperitoneum and Trendelenburg positioning; immediately before extubation; 5 minutes after extubation; and 1, 24 and 48 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ezgi Budak Ozyalcın

Medical Doctor

Istanbul University

Study Sites (1)

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